Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12

Strep Throat Clinical Trial

Official title:

Study to Evaluate the Safety and Human Tolerance of the Oral Probiotic Streptococcus Salivarius K12: A Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380270
• Other study ID #: LUMHS/B12/Temp/14.04.2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene.

Description:

Numerous clinical studies have delved into the therapeutic potential of Streptococcus salivarius K12 across a broad spectrum of health conditions including prevention of recurrent upper respiratory tract infection such as such as sore throat, tonsillitis, and pharyngitis, in both adults and pediatrics. However, despite this extensive exploration, only limited clinical trials have explicitly focused on assessing its safety profile and human tolerance. Therefore, the primary objective of the present clinical trial is to bridge this gap in knowledge by meticulously evaluating the safety and tolerance of Streptococcus salivarius K12 in human subjects. By conducting comprehensive assessments and closely monitoring participants' responses, this trial aims to elucidate crucial insights into the safety profile and human tolerance of this probiotic strain. The findings gleaned from this clinical trial will not only enhance our understanding of Streptococcus salivarius K12's safety but also provide invaluable guidance for its future evidence-based therapeutic applications in oral health management and disease prevention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults, both male and female, aged 18 to 60 years.

• Stable health condition with no acute illness at the time of enrollment.

• BMI 18.5-35 kg/m2

• No known food allergies or intolerances to probiotics

• All clinical chemistry, hematology and urinalysis parameters and vital signs (blood pressure, respiratory rate, temperature, heart rate) within clinically acceptable ranges.

• Ability and willingness to provide informed consent.

• Must be willing to comply with study procedures and attend scheduled visits.

Exclusion Criteria:

• Individuals with a history of severe allergies or adverse reactions to probiotics or any of the components of the study product.

• Participants with a recent history of oral surgery or dental procedures within the past 4 weeks.

• Individuals with severe dental problems or undergoing active dental treatment.

• Individuals with a known diagnosis of systemic diseases affecting the oral cavity (e.g., oral cancer, Sjögren's syndrome).

• Individuals with compromised immune systems, or a history of immunodeficiency disorders or undergoing immunosuppressive therapy.

• Pregnant or breastfeeding females.

• Current smokers or individuals who have quit smoking within the past 6 months.

• Individuals currently using antibiotics or have used them within the past 4 weeks.

• Individuals with a history of gastrointestinal disorders (e.g., inflammatory bowel disease, irritable bowel syndrome).

• Individuals with unstable metabolic diseases/disorders, heart failure or a history of endocarditis.

• Frequent user of alcohol or over the counter laxatives, or herbal-based supplements (but not vitamin supplements), or prescription drugs that may potentially influence the biomarkers to be measured in the study.

• Those with any chronic systemic illness that might affect participation in the trial or interpretation of results.

• Participants currently enrolled in another clinical trial involving probiotics or oral health interventions.

• Those unable to adhere to the study protocol or unlikely to complete the study period due to anticipated relocation or other personal reasons.

• Any other condition or circumstances that, in the opinion of the investigator, might compromise the safety of the participant or the validity of the study results.

Related Conditions & MeSH terms

• Strep Throat

Intervention

Dietary Supplement:
• Oral probiotic Streptococcus salivarius K12 sachet
Bactoblis® (containing 10 bittion CFU of S. salivarius K12)

Locations

Country	Name	City	State
Pakistan	Liaquat University of Medical and Health Sciences	Jamshoro

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on oral health physical condition	Incidence of physical abnormality in pharynx, tongue, teeth, gums and oral mucosa	3-months
Primary	Effect on other physical features	Incidence of any physical abnormality in the skin, eyes, ears, nose, throat, and mental health	3-months
Primary	Effect on vital signs	Any changes in the heart rate (heart beats per minute (bpm))	3-months
Primary	Effect on vital signs	Any changes in the respiratory rate (number of breaths per minute)	3-months
Primary	Effect on vital signs	Any changes in the blood pressure (both systolic pressure and diastolic pressure)	3-months
Primary	Effect on vital signs	Any changes in the body temperature	3-months
Primary	Effect on blood biochemistry	Any changes in the liver function tests (Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase)	3-months
Primary	Effect on blood biochemistry	Any changes in the renal function tests (serum creatinine, serum urea, blood urea nitrogen)	3-months
Primary	Effect on blood biochemistry	Any changes in the lipid profile tests (serum total cholesterol, serum triglycerides, serum high density lipoprotein-cholesterol, serum low density lipoprotein-cholesterol)	3-months
Primary	Effect on blood biochemistry	Any changes in the blood glucose levels	3-months
Primary	Effect on blood electrolytes balance	Electrolyte tests (e.g., sodium, potassium, chloride, bicarbonate)	3-months
Primary	Effect on hematology	Full blood count	3-months
Primary	Incidence of inflammation	C-recative protein (CRP) blood test	3-months
Primary	Incidence of gastrointestinal side effects	Abdominal pain, bloating, gastric reflux, nausea, vomiting, diarrhea, and gas or flatulence	3-months
Primary	Incidence of Adverse events (AEs)	Any adverse events that may occur during the study period	3-months